Clinical Hold Decision

A clinical hold is the mechanism that CDER uses when it does not believe, or cannot confirm, that the study can be conducted without unreasonable risk to the subjects/patients. If this occurs, the Center will contact the sponsor within the 30-day initial review period to stop the clinical trial. CDER may either delay the start of an early-phase trial on the basis of information submitted in the IND, or stop an ongoing study based on a review of newly submitted clinical protocols, safety reports, protocol amendments, or other information. When a clinical hold is issued, a sponsor must address the issue that is the basis of the hold before the order is removed.

CDER's authority concerning clinical holds is outlined in Federal regulations. The regulations specify the clinical hold criteria that CDER applies to various phases of clinical testing. In addition, all clinical holds are reviewed by upper management of CDER to assure consistency and scientific quality in the Center's clinical hold decisions.

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.